S244: EFFECT OF ANTI-SPIKE NEUTRALIZING MONOCLONAL ANTIBODIES ON COVID-19 PROGRESSION AND TIME TO VIRAL CLEARANCE IN PATIENTS WITH HEMATOLOGICAL MALIGNANCIES AND SARS-COV-2 INFECTION: THE GIMEMA EXPERIENCE
Authors: V. Marasco, A. Guidetti, A. Piciocchi, A. Candoni, M. Bocchia, R. Bruna, P. Musto, A. Visentin, M. Turrini, A. Tucci, C. Selleri, E. Crea, P. Fazi, F. Passamonti, P. Corradini
Journal: HemaSphere (2022)

Background: Patients with hematological malignancies (HM) infected with SARS-CoV-2 have a higher risk of developing severe coronavirus disease (COVID-19) with consequent death, due to immune system impairment. Anti-spike Neutralizing Monoclonal Antibodies (nMoAbs) are indicated for the treatment of paucisymptomatic COVID-19 patients, but evidence of safety and efficacy among HM subjects is still lacking. Aims: To assess the efficacy of different nMoAbs approved by Agenzia Italiana del Farmaco (AIFA) on HM patients affected by paucisymptomatic SARS-COV-2. Methods: Multicenter retrospective observational study at ten sites in Italy, which enrolled consecutive patients with SARS-CoV-2 infection and treated with nMoAbs from February 2020 to December 2021. Only HM subjects on treatment or in disease remission within 6 months from treatment discontinuation with paucisymptomatic SARS-COV-2 infection were included. nMoAbs approved by AIFA include Bamlanivimab, Bamlanivimab/Etesevimab, Casirivimab/Imdevimab, Sotrovimab, and Regdanvimab. The primary endpoint was to assess the time to SARS-CoV-2 molecular swab negativization. A comparison to an historical control not receiving nMoAbs was assessed. Secondary endpoints consisted in evaluation of hospitalization rate due to COVID-19, including intensive care unit (ICU) admission rate due to respiratory failure, and safety assessment. Results: Overall 51 HM patients (median age 62 years; 35% women) were evaluated. Seventeen of them had non-Hodgkin lymphomas, 9 multiple myeloma, 6 chronic lymphocytic leukemia, 6 acute myeloid leukemia, 3 Hodgkin lymphoma, 2 acute lymphoblastic leukemia, 2 myeloproliferative neoplasm, 1 Waldenstrom macroglobulinemia and 5 had other HM diagnosis. Thirty-six patients were on active treatment, whereas 11 had completed their therapies within 6 months from nMoAbs administration, for 4 patients data were missing. In 7 subjects the last treatment was chemotherapy, in 19 immunotherapy with or without chemotherapy, in 9 target therapy, in 4 autologous stem cell transplantation, in 2 allogeneic stem cell transplantation, for 4 patients data were missing. Detailed description of patients’ characteristics is reported in table 1. Twenty-six patients were treated with Bamlanivimab/Etesevimab, 17 with Casirivimab/Imdevimab, 3 with Bamlanivimab, and 2 with Sotrovimab, for 3 patients data were missing. Median time to SARS-CoV-2 molecular swab negativization was evaluable in 41 subjects and was 17 days (min 5, IQR 12-26, max 174). This result compared well with the previous finding of 28 days reported in an historical group of HM patients not treated with nMoAbs. We did not find any subpopulation, according to age, diagnosis, period of infection or type of nMoAbs who achieved a major benefit from nMoAbs treatment. The rate of hospitalization due to COVID-19 progression was 19% (10/51), with an extremely low percentage of patients requiring ICU admission due to sever COVID-19 (2%,1/51). Most frequent side effects included chills (8%), diarrhea (6%), headache (2%), nausea (2%) and vomiting (2%). Image:Summary/Conclusion: Among paucisymptomatic SARS-CoV-2 positive HM patients on active treatment or in disease remission within 6 months from treatment discontinuation, the administration of nMoAbs substantially reduced the time to swab negativization compared to an historical control of HM subjects. This treatment was also able to reduce the rate of hospitalization and death due to COVID-19 progression in this high risk group.